Text Size

A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
HCA International Limited
Theradex
Information provided by (Responsible Party):
Immodulon Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01308762
First received: February 16, 2011
Last updated: November 8, 2012
Last verified: September 2012
History of Changes
  Purpose

To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.


Condition Intervention Phase
Melanoma
 Biological: Heat killed whole cell M. obuense (IMM-101) 0.1 mg
Biological: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg
Biological: Heat killed whole cell M.obuense (IMM-101) 1.0 mg
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: An Intra-patient Placebo-controlled, Phase I Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 (Heat-killed Mycobacterium Obuense) in Adult Melanoma Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Immodulon Therapeutics Ltd:

Primary Outcome Measures:
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

    Safety and tolerability were measured with respect to:

    1. Safety measurements
    2. Local tolerability at the site of intradermal injection
    3. Incidence of adverse events.


Secondary Outcome Measures:
  • Administration Site Reactions [ Time Frame: Day -3 to Day 56 ] [ Designated as safety issue: Yes ]
    Local skin reactions are viewed as a normal and predicted reaction to exposure to a preparation of mycobacterial antigens. All patients experienced administration site reactions and all reactions were examined and characterised. However only those reported as adverse events are presented here.


Enrollment: 19
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMM-101

Patients received an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28. Doses used were:

'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'

 Biological: Heat killed whole cell M. obuense (IMM-101) 0.1 mg

Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.

Dose levels to be administered are 0.1 mg, 0.5 mg and 1.0 mg.

Other Names:
  • IMM-101
  • Mycobaterium obuense
Biological: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg
Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.
Other Names:
  • IMM-101
  • Mycobaterium obuense
Biological: Heat killed whole cell M.obuense (IMM-101) 1.0 mg
Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.
Other Names:
  • IMM-101
  • Mycobaterium obuense

Detailed Description:

The proposed study is a first-in-man, placebo-controlled, dose escalation trial to evaluate the safety and tolerability of three different doses of IMM-101 administered intradermally to melanoma patients. Additionally, the study aims to characterize local responses to this vaccine in order to delineate unexpected / unacceptable local reactions from those indicative of appropriate immunological response in this patient group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • confirmed diagnosis of disease free stage III or stage IV melanoma (with or without metastases) or stable disease (if with metastases) and receiving no other treatment
  • willing to use effective contraception for the duration of the study
  • able to comply with the requirement to complete a diary card

Exclusion Criteria:

  • Pregnant or lactating females
  • Major surgery within the 14 days preceding the screening visit
  • Suspicion of a previous infection with mycobacteria including previous tuberculosis (TB) prophylaxis
  • Treatment with another investigational medicinal product within the last 30 days prior to the screening visit
  • Previous treatment with M. vaccae
  • Exposure to Bacille Calmette Guérin vaccine (BCG) within the last 12 months
  • Concurrent uses of drugs likely to reduce inflammation at the local injection site or dampen/modulate the immune system
  • Depot injection of corticosteroids within 6 weeks of the screening visit or chronic systemic corticosteroids in the 2 weeks prior to the screening visit
  • Ongoing treatment with radiotherapy, cytotoxic chemotherapy or chemotherapy in the last 30 days prior to the screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308762

Locations
United Kingdom
HCA Clinical Trials Unit, 79 Harley Street,
London, United Kingdom, W1G 8PZ
Sponsors and Collaborators
Immodulon Therapeutics Ltd
HCA International Limited
Theradex
Investigators
Principal Investigator: Justin Stebbings, Professor Imperial College Healthcare NHS Trust
  More Information

No publications provided by Immodulon Therapeutics Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Immodulon Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT01308762     History of Changes
Other Study ID Numbers: IMM-101-001, 2009-012447-42
Study First Received: February 16, 2011
Results First Received: March 30, 2011
Last Updated: November 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 21, 2013